System for providing stimulation to a patient

Abstract

The present disclosure relates to a system (100) for providing stimulation to a patient, in particular stimulation to a left bundle branch area of the heart (701) of the patient, the system comprising: a stimulation pulse generator (10, 610); at least one electrode (30, 620, 800) having a distal end (31) for being engaged with the patient and a proximal end for being engaged with the generator (10, 610), the electrode (30, 620, 800) being configured to be implanted at least partially in the septum (713) of the heart (701) of the patient, and to provide stimulation to the patient, wherein the distal end (31) comprises a fixing portion configured to facilitate implanting in the septum (713); a sheath (50) having a three- dimensional opening for guiding the at least one electrode (30, 620, 800) for implanting of the electrode (30, 620, 800); wherein the generator (10, 610), the electrode (30, 620, 800) and the sheath (50) are adapted for use in combination with each other.

Description

[0001] System for providing stimulation to a patient

[0002] The present invention relates to a system, method, and computer program for providing stimulation to a patient. More specifically, the invention pertains to a system and method for providing targeted electrical stimulation to the left bundle branch area of the heart to enhance cardiac function and treat various cardiac conditions.

[0003] Cardiac rhythm management devices, such as pacemakers and implantable cardioverterdefibrillators (ICDs), have been developed to provide electrical stimulation to the heart in order to treat arrhythmias and to improve cardiac function. Traditional pacing systems typically stimulate the heart at the right atrium and / or right ventricle to induce contraction. However, this can result in non-physiological activation patterns, potentially leading to or exacerbating heart failure due to dyssynchronous ventricular contraction.

[0004] Cardiac resynchronization therapy (CRT) has emerged as a valuable means for heart failure patients with ventricular dyssynchrony, typically involving the stimulation of both the left and right ventricles to resynchronize cardiac contractions. Traditionally, CRT is accomplished using epicardial leads placed on the surface of the heart or by transvenous leads positioned within the coronary sinus to indirectly stimulate the left ventricle.

[0005] Recent advances have focused on more physiological pacing techniques, such as direct left bundle branch area pacing (LBBAP), to mimic the heart's natural conduction pathway. Pacing the left bundle branch area shows promise in providing a more synchronized activation of the ventricles and improving cardiac function, yet existing systems and methods still face various challenges. In particular, the prior art lacks medically approved systems that cover all necessary components in order to smoothly perform implantation and stimulation of the left bundle branch area. The present invention seeks to address these issues by introducing improvements over the known systems and methods.

[0006] The above-mentioned objects and other objects, which become apparent from the following description, are solved by the subject-matter of the independent claims. Further embodiments are subject of the dependent claims.

[0007] A first aspect of the disclosure is related to a system for providing stimulation to a patient, in particular stimulation to a left bundle branch area of the heart of the patient, the system comprising: a stimulation pulse generator; at least one electrode (short for electrode lead) having a distal end for being engaged with the patient and a proximal end for being engaged with the generator, the electrode being configured to be implanted at least partially in the septum of the heart of the patient, and to provide stimulation to the patient, wherein the distal end comprises a fixing portion configured to facilitate implanting in the septum; a sheath having a three-dimensional opening for guiding the at least one electrode for implanting of the electrode; wherein the generator, the electrode and the sheath are adapted for use in combination with each other. The at least one electrode is an epicardial lead or a transvenous lead. In one embodiment, the system comprises a single electrode.

[0008] The system has the advantage to provide a combined set of components, i.e., a generator, an electrode, and a sheath that can be easily used for implanting and stimulating. Further, as these components are adapted for use in combination with each other, they allow to be medically approved. This therefore provides advantages over known individual components, which necessitate off-label usage. The system has the further advantage to enhance cardiac function and treat various cardiac conditions. The system may be a conduction-system- pacing-system.

[0009] In a further embodiment of the system, the generator may comprise at least one predefined parameter configured to indicate a position of the electrode, preferably of the distal end of the electrode when implanted in the septum of the heart. In a further embodiment of the system, the generator may comprise stimulation and / or diagnostic functions that are configured to be dependent upon a location of the distal end of the electrode.

[0010] In a further embodiment of the system, the generator may comprise simulation synchronized to a sensed atrial signal of the patient’s heart, wherein the atrial signal is, e.g., detected by a measuring pole of the electrode. The received atrial signal may be transmitted to the generator and processed there for generation of the stimulation pulse, e.g. synchronized to the sensed atrial signal.

[0011] In a further embodiment of the system, the fixing portion may comprise a helical structure that is, e.g., fixedly or removably attached to the distal end of the electrode, having a length of 0.1 mm to 5 mm, preferably 0.5 mm to 4 mm, preferably 1 mm to 3 mm, most preferably 1.5 mm to 1.8 mm, further preferably 1.5 mm to 3 mm the helical structure configured to allow the distal end of the electrode to be screwed in the septum, wherein the helical structure is preferably a piece separate from the electrode such that the helical structure can be at least partially removably attached to the electrode. In one embodiment of the system the distal end of the at least one electrode may be configured to be screwed in the septum to a depth of at least 5 mm. Alternatively, the helical structure may be screwed in or out of a distal end portion of the electrode.

[0012] In a further embodiment of the system, the fixing portion may comprise a first pole and the electrode comprises a second pole in proximity of the distal end, wherein the first pole and / or the second pole is preferably between 1 mm to 10 mm, preferably 2 mm to 9 mm, preferably 3 mm to 8 mm, preferably 4 mm to 7 mm, preferably 5 mm to 6 mm spaced apart from the distal end, the first and the second pole configured to provide stimulation to the patient, wherein the electrode is preferably a bipolar electrode, wherein the second pole has preferably the shape of a ring, preferably having a length along the longitudinal direction of the electrode of at least 0.5 mm, preferably at least 1 mm, preferably at least 1.5 mm, preferably at least 2 mm and / or of at most 5 mm, preferably at most 4 mm, preferably at most 3 mm, preferably at most 2 mm. In one embodiment the first electrode may have the shape of a ring. Alternatively, the helical structure of the fixing portion may form the first electrode. The second pole may be a ring-shaped pole accommodated with a pre-defined distance proximally from the first pole. Alternatively, the second pole is a shock coil.

[0013] In a further embodiment of the system, the sheath may have an essentially elongated, tubular shape and an inner surface facing the opening, wherein the inner surface and / or its inner lumen is configured so as to facilitate guiding the electrode, wherein in one embodiment the inner surface is configured to guide the electrode with low friction.

[0014] In a further embodiment of the system, the stimulation may be configured to provide left bundle branch area pacing (LBBAP), wherein the system is preferably a conduction system pacing system.

[0015] In a further embodiment of the system, the generator may be one or more of an implantable pulse generator, IPG, an implantable cardioverter defibrillator, ICD, a generator for cardiac resynchronization therapy with a defibrillator, CRT-D, a generator for cardiac resynchronization therapy with a pacemaker, CRT-P. In one embodiment, the generator may be configured to provide stimulation according to DX-technology and / or VDD mode to the patient, for example based on a sensed atrial signal. In one embodiment, the generator comprises an increased atrial sensitivity which can be used for the so-called DX-technology that allows to detect atrial fibrillation (AF) from sensed atrial signals of the patient’s heart, processes such detected signals and manages AF once detected by proper stimulation. The VDD mode uses sensed signals of the atrium and the ventricle of the patient for pacing. The VDD mode is a physiological atrial and ventricular synchronous ventricular pacing mode, wherein, in one embodiment, a single lead with a floating dipole consisting of, e.g., two ring poles to detect atrial signals may be used.

[0016] In a further embodiment of the system, the generator may comprise a recess for being engaged with the proximal end of the electrode, the recess comprising a first and a second pole for transmitting the stimulation signal to the electrode when the electrode is engaged with the recess. In one embodiment, the generator may comprise a first and a second recess, wherein the first recess is configured for engagement with a first branch of an electrode, or a first electrode and the second recess is configured for engagement with a second branch of the electrode or a second electrode. The second recess comprises a terminal, preferably an IS-1 terminal, wherein the second electrode is preferably an electrode configured to be implanted to provide stimulation to a left bundle branch area of the heart of the patient or not to provide stimulation to a left bundle branch area of the heart of the patient. Alternatively, the second recess comprises a DF4 terminal if a corresponding pole of the second branch is a shock pole. The first branch and the second branch may be connected by a switch device located distally from their proximal ends.

[0017] In one embodiment, the electrode comprises the first pole and the second pole and additionally a third pole and, if applicable, a fourth pole, wherein the third pole and the fourth pole is located proximally from the second pole, wherein each one of the third pole and, if applicable, the fourth pole is a ring-shaped pole accommodated with a pre-defined distance from each other. If applicable, the third and the fourth electrode may form a dipole. In one embodiment the third pole and, if applicable, the fourth pole are configured to sense atrial signals of the patient’s heart as floating poles. Accordingly, they are located in an atrium, e.g. in the right atrium, of the heart if the electrode is properly anchored within the patient’s heart tissue with its distal end. The first pole may be a helical structure forming the fixation portion and, at the same time, operating as a stimulation pole. The second pole may be located 1 mm to 10 mm, preferably 2 mm to 10 mm, preferably 3 mm to 10 mm from the proximal end of the first pole and may be formed as a shock coil.

[0018] In one embodiment, the generator may comprise an additional recess or a left ventricular electrode (CS electrode, single to tetrapolar) which may provide an electrical stimulation of the heart’s tissue synchronized to the sensed atrial signal.

[0019] In a further embodiment of the system, the generator, e.g. its processor, may comprise a programming interface comprising a switch configured to indicate whether or not the electrode is implanted in the left bundle branch area of the heart of the patient, wherein the switch is configured to be activated when the electrode is implanted in the left bundle branch area of the heart of the patient. The algorithm provided by the processor of the generator may realize a function of the generator, wherein the algorithm operates differently depending on the value representing the activation state of the switch and leading to different states of the function.

[0020] In a further embodiment of the system, when the switch is activated, the information that the electrode is implanted in the left bundle branch area of the heart of the patient is configured to be indicated to a human, such as the patient, wherein preferably a brady parameter screen and / or a follow-up screen is / are configured to display this information, wherein this information is preferably configured to be made available on programmer printouts, wherein this information is preferably configured to be uploaded to remote monitoring system, HMSC.

[0021] In a further embodiment of the system, when the switch is activated, a human such as the patient is allowed to enter left bundle branch, LBB, myocardial-only and / or Bundle branch block, BBB, correction capture threshold(s) separately or in combination for a substantially manual LV-threshold-test.

[0022] In a further embodiment of the system, providing stimulation to the patient is dependent on the information.

[0023] In a further embodiment of the system, the opening of the sheath comprises a stylet and / or wherein the sheath comprises a stylet, wherein the sheath is preferably a catheter. The stylet may support the implantation of the electrode.

[0024] In a further embodiment of the system, the sheath comprises a first deformation in a first plane and a second deformation in a second plane, the second plane being different from the first plane.

[0025] The above and below described sheath is an improved sheath, in particular with respect to stability of its shape, which supports a positioning and anchoring of an electrode in the septum of a human heart to the greatest extent. According to an embodiment of the sheath, the sheath is configured for implanting an electrode in the septum of a human heart. The sheath comprises an elongated sheath shaft which defines an inner lumen (i.e. three-dimensional opening) for guiding the at least one electrode. The sheath shaft has a flexible distal end portion, wherein the distal end portion is preshaped in such a way that it describes a helical curve. This means that the sheath shaft, including the opening located therein, describes a helical curve.

[0026] A helical curve is defined as at least one portion of a three-dimensional curve which winds continuously about a helix axis and thereby also has a component in longitudinal direction of the helix axis. It is thus, e.g., a three-dimensional spiral, which winds out of the plane like a type of snail shell. The helical curve may be, e.g., a portion of a three-dimensional spiral whose radius varies (and, e.g., continuously increases along the helix axis).

[0027] The helically curved configuration of the distal end portion of the sheath shaft prevents discontinuities due to kink susceptibilities. In addition, it is facilitated that the sheath shaft (in portions) lies stably in a cardiac vein and simultaneously shapes itself in the cardiac chamber (in another, more distal portion), such that it may support an implantation of an electrode in the septum.

[0028] In one embodiment, the distal end portion of the sheath shaft is preshaped in a way that a local radius of the helical curve continuously increases along the sheath shaft from its distal to its proximal end.

[0029] In particular, in one embodiment, the local radius may exponentially increase from the distal to the proximal end of the distal end portion of the sheath shaft. For example, the helical curve may be described in polar coordinates in a top view along the helix axis, about which the helical curve winds, wherein a distal end of the sheath shaft is located at the origin of the coordinate system. In this case, the helical curve may be parameterized by a continuously changing polar angle, starting from the origin, wherein the local radius of the helical curve increases exponentially to the polar angle passed through. In one embodiment, a local gradient along the helical curve may be variable (relative to the helix axis). The local gradient of the helical curve may increase from the proximal to the distal end of the distal end portion. Thus, the distal end may align, e.g., largely in the direction of the helix axis of the helical curve. For example, the distal end may face perpendicularly to the septum of the heart during the implantation of the electrode within the cardiac chamber.

[0030] According to one embodiment, the helical curve winds about a helical axis and thereby covers an angle of a maximum of 340°. For example, in a top view along the helix axis, about which the helical curve winds, the helical curve may be described in polar coordinates, wherein a distal end of the sheath shaft is located at the origin of the coordinate system. In this case, a polar angle interval of e.g., 0 to a maximum of 340° may suffice to trace the entire helical curve of the distal end portion. Visually, this means that the helical curve according to this embodiment describes almost a maximum of a complete circle (namely at least 20° less than a complete circle) in the top view.

[0031] According to another embodiment, the covered angle lies, in contrast, in the range from 4 rad to 20 rad. This embodiment thus visually allows that the distal end portion of the sheath shaft winds multiple times (up to 3 times) completely around the helix axis.

[0032] By indicating that the distal end portion is flexible, it should be expressed that the distal end portion is elastically malleable, wherein the distal end portion is pre-shaped in such a way that is adopts the helically curved shape at least in an unloaded (non-deformed) state.

[0033] The sheath shaft may consist, e.g., at least partially of a relatively flexible plastic material, like silicone. For example, such a sheath shaft may be produced in a so-called reflow process, in which one or more tube segments made from plastic are initially applied onto at least one wire. The at least one wire is subsequently removed so that at least one lumen remains.

[0034] In one embodiment, the sheath shaft has a (not necessarily monotonously) decreasing stiffness from the proximal to the distal end. In other words, the sheath shaft may become increasingly softer from the proximal to the distal end. In particular, the stiffness may monotonously decrease from the proximal to the distal end. Due to the decrease in the stiffness of the sheath shaft from proximal to distal end, the sheath shaft in the proximal portion may guarantee a good maneuverability and simultaneously be sufficiently flexible in the distal portion to be able to adapt well to the vascular tree.

[0035] The sheath shaft may comprise, e.g., multiple segments of different stiffness. The different stiffnesses of the individual segments may thereby be achieved, e.g., through tube segments made of materials of different hardnesses, by which means the stiffness may be varied.

[0036] According to one embodiment, the sheath shaft may have a soft tip at a distal end. This means that a tip at the distal end is particularly soft (i.e., is less stiff) in comparison to other portions of the sheath shaft and in particular in comparison to other portions of the distal end portion. This may be an atraumatic tip, which prevents injuries to the vessels or other tissues due to its soft configuration.

[0037] In a further embodiment, the sheath is configured to be cut, e.g., in longitudinal direction, so as to facilitate removal of the sheath preferably after implanting the electrode, wherein preferably a tool can be used in order to cut the sheath. Alternatively, the slitting may be provided without separate tool.

[0038] In a further embodiment, the electrode (e.g. a CRT-D electrode) comprises a third electrode pole and a fourth electrode pole that form together a dipole.

[0039] A second aspect of the disclosure is related to a method for providing stimulation to a patient, in particular stimulation to a left bundle branch area of the heart of the patient, comprising: using the system as described in the present disclosure.

[0040] A third aspect of the disclosure is related to a method for providing stimulation to a patient, in particular stimulation to a left bundle branch area of the heart of the patient, comprising: providing a stimulation pulse generator; providing at least one electrode having a distal end for being engaged with the patient and a proximal end for being engaged with the generator, the electrode being configured to be implanted at least partially in the septum of the heart of the patient, and to provide stimulation to the patient, wherein the distal end comprises a fixing portion configured to facilitate implanting in the septum; providing a sheath having a three-dimensional opening for guiding the at least one electrode for implanting of the electrode; wherein the generator, the electrode and the sheath are adapted for use in combination with each other.

[0041] A fourth aspect of the disclosure is related to a method for implanting an electrode, preferably an electrode of the system as described in the present disclosure, comprising: placing a sheath at least partially in the septum of the heart of a user; guiding at least one electrode at least partially through the sheath, the electrode preferably having a distal end for being engaged with the patient and a proximal end for being engaged with a generator, the electrode being configured to be implanted at least partially in the septum of the heart of the patient, and to provide stimulation to the patient, implanting the electrode by at least partially fixing the electrode in the septum, preferably in the left bundle branch area of the heart of the user, optionally removing the sheath; optionally cutting the sheath.

[0042] A fifth aspect of the disclosure is related to a computer program comprising instructions which, when the program is executed by a computer or processor, e.g. a processor of the generator, causes the computer / processor to carry out any one of the methods described in here. The processor of the generator is configured to produce the respective, above mentioned stimulation signals that are transmitted by the at least one electrode to the patient’s body for stimulation. In one embodiment the stimulation signals may be produced by the generator’s processor for ventricular stimulation based on sensed atrial signals. These signals are, e.g., determined by the processor during cyclic determination of atrio-ventricular conduction (so-called fusion pacing).

[0043] Any features and or advantages of the aspects as described in here can be combined with one another as understood by the skilled person.

[0044] Whether described as method steps, computer program and / or means, the functions described herein may be implemented in hardware, software, firmware, and / or combinations thereof. If implemented in software / firmware, the functions may be stored on or transmitted as one or more instructions or code on a computer-readable medium. Computer-readable media include both computer storage media and communication media including any medium that facilitates transfer of a computer program from one place to another. A storage medium may be any available media that can be accessed by a general purpose or special purpose computer. By way of example, and not limitation, such computer-readable storage media can comprise RAM, ROM, EEPROM, FPGA, CD / DVD or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to carry or store desired program code means in the form of instructions or data structures and that can be accessed by a general-purpose or special-purpose computer, or a general-purpose or special-purpose processor. Any means for controlling or the like as described herein may also be implemented in hardware, software, firmware, and / or combinations thereof, for example, by means of one or more general-purpose or specialpurpose computers, and / or a general-purpose or special-purpose processors.

[0045] In the following, embodiments of the above invention are described, by way of example only. Reference is made to the following accompanying figures:

[0046] Fig. 1 illustrates a system according to a first aspect;

[0047] Fig. 2 illustrates a generator;

[0048] Fig. 3 illustrates an electrode accommodated within a sheath;

[0049] Fig. 4 illustrates a sheath and an electrode;

[0050] Fig. 5 illustrates a method according to an embodiment,

[0051] Fig. 6 shows a single lead CRT system in a side view; and

[0052] Fig. 7 depicts a cross section of a human heart with an implanted electrode. Subsequently, embodiments will be outlined, primarily with reference to the above Figures. It is noted that further embodiments are certainly possible, and the below explanations are provided by way of example only, without limitation.

[0053] Figs. 1 to 4 illustrate a system according to a first aspect. The system 100 is for providing stimulation to a patient, in particular stimulation to a left bundle branch area of the heart of the patient. The system 100 comprises a stimulation pulse generator 10 and at least one electrode 30 having a distal end 31 for being engaged with the patient and a proximal end 38 for being engaged with the generator 10. The electrode 30 is configured to be implanted at least partially in the septum of the heart of the patient, and to provide stimulation to the patient, wherein the distal end 31 comprises a fixing portion configured to facilitate implanting in the septum. The system further comprises a sheath 50 having an elongated essentially cylindrical three-dimensional opening for guiding the at least one electrode 30 for implanting of the electrode 30. The generator 10, the electrode 30 and the sheath 50 are adapted for use in combination with each other.

[0054] The sheath 50 may comprise an elongated shaft and / or it may have a helically curved shape at its distal end portion as described above. The sheath 50 may have a local radius of the helical curve that increases along the sheath shaft from its distal to proximal end.

[0055] Fig. 5 illustrates a method 1000 according to a fourth aspect of the disclosure, the method is for implanting an electrode, preferably an electrode of the system as described in the present disclosure. The method comprises the following steps: placing 200 a sheath at least partially in the septum of the heart of a user; guiding 300 at least one electrode at least partially through the sheath, the electrode preferably having a distal end for being engaged with the patient and a proximal end for being engaged with a generator, the electrode being configured to be implanted at least partially in the septum of the heart of the patient, and to provide stimulation to the patient, implanting 400 the electrode by at least partially fixing the electrode in the septum, preferably in the left bundle branch area of the heart of the user, optionally removing the sheath; optionally cutting the sheath. In Fig. 6 a single lead CRT system without sheath is shown. It comprises a stimulation generator 610 of the CRT-D type. An electrode 620 is connected to the generator at a header having two recesses. The electrode 620 comprises a distal first pole (tip pole) 640 having a helix for deep implantation and fixation within the septum of the heart’s ventricle. The first pole 640 is further configured to detect electrical signals of the heart and to stimulate the left bundle branch area for LBBAP. The electrode 620 further comprises a helical shock pole 650 for provision of defibrillation signals to the patient’s heart wherein the shock pole 650 is located proximal from the first electrode pole 640. Additionally, the electrode 620 comprises a dipole 660 having two ring poles spaced from another in longitudinal direction of the electrode 620. This dipole 660 is configured to detect intrinsic atrial pulses and located within the right atrium when correctly implanted in the patient’s heart. The dipole 660 is located proximal from the shock pole 650. Proximal from the dipole 660 the electrode 620 comprises a switch device 670 that splits up the electrode 620 to a first electrode branch 680 and a second electrode branch 690. The first electrode branch 680 mechanically and electrically connects the ventricular first pole 640 and the helical shock electrode pole 650 to the generator 610 and the second electrode branch 690 mechanically and electrically connects the dipole 660 to the generator 610.

[0056] Fig. 7 shows a human heart 701 into which a four-pole CRT-D electrode 800 is implanted. This CRT-D electrode 800 is guided through the upper vena cava 712 and the right atrium 702 into the right ventricle 703. Here, it is anchored at a deep position of the septum 713 separating the right ventricle 703 and the left ventricle 705 from each other. For proper fixing of the CRT-D electrode 800, a first electrode pole 801 of this CRT-D electrode 800 is designed as helical electrode pole. It is screwed into the septum 713 so that it almost reaches the left ventricle 705 (but still stays within the septum 713).

[0057] The CRT-D electrode 20 further comprises a second electrode pole 802 that is designed as shock coil. It is located, in the implanted state of the CRT-D electrode 800, within the right ventricle 703 and is configured to provide a shock pulse to the heart 701 to achieve a defibrillation of the heart 701 in case of a tachycardic episode. The CRT-D electrode 800 furthermore comprises a third electrode pole 803 and a fourth electrode pole 804 that form together a dipole 806 (i.e., one of the third electrode pole 803 and the fourth electrode pole 804 serves as counter electrode for the respective other electrode pole). Since the third electrode pole 803 is located proximally of the second electrode pole 802 and since the fourth electrode pole 804 is located proximally of the third electrode pole 803, the dipole 806 is also referred to as proximal dipole 806. The proximal dipole 806 serves for sensing atrial signals of the heart 701 to be able to apply ventricular stimulation by the first electrode pole 801 and / or the second electrode pole 802 in response to the sensed atrial signals. For example, the proximal dipole 806 is arranged so that it is floating in the atrium 702 after implantation of the electrode 800. Floating means that the dipole 806 is not (additionally) fixed to the cardiac tissue. Thereby, the dipole 806 may float freely in the atrium 702 or rest against the wall of the atrium 702. The distance between the facing ends of the third electrode pole 803 and the fourth electrode pole 804 (forming the dipole 806) is in the range from 10 mm to 20 mm, in particular from 10 mm to 13 mm. The distance between a distal end of the fourth electrode pole 204 and a proximal end of the first electrode pole 201 is, e.g., in a range from 100 mm to 200 mm, in particular from 100 mm to 140 mm, in particular from 100 mm to 125 mm. At its distal end the electrode 800 is connected to a generator (not shown) for processing the sensed atrial signals and for producing the stimulation signals based on the received atrial signals. For implantation of the electrode 800 at the pre-defined position shown in Fig. 7, an appropriate sheath (not shown) is used.

[0058] It is noted that the above examples / embodiments may be combined with further aspects as described herein and details of the examples may also be omitted, as will be understood by the skilled person. Reference numerals

[0059] 10 generator

[0060] 11 recess

[0061] 12 first pole of generator

[0062] 13 second pole of generator

[0063] 15 second recess, IS-1 terminal

[0064] 30 electrode

[0065] 31 distal end, helical structure

[0066] 35 second pole

[0067] 38 proximal end

[0068] 50 sheath

[0069] 100 system

[0070] 1000 method

[0071] 200 method step

[0072] 300 method step

[0073] 400 method step

[0074] 610 generator

[0075] 620 electrode

[0076] 640 first pole

[0077] 650 shock electrode pole

[0078] 660 dipole

[0079] 670 switch device

[0080] 680 first electrode branch

[0081] 690 second electrode branch

[0082] 701 human heart

[0083] 702 right atrium

[0084] 703 right ventricle

[0085] 704 left atrium

[0086] 705 left ventricle

[0087] 712 upper vena cava

[0088] 713 septum 800 CRT-D electrode

[0089] 801 first electrode pole

[0090] 802 second electrode pole

[0091] 803 third electrode pole 804 fourth electrode pole

[0092] 806 dipole

Claims

Claims1. System (100) for providing stimulation to a patient, in particular stimulation to a left bundle branch area of the heart (701) of the patient, the system comprising: a stimulation pulse generator (10, 610); at least one electrode (30, 620, 800) having a distal end (31) for being engaged with the patient and a proximal end (38) for being engaged with the generator (10, 610), the electrode (30, 620, 800) being configured to be implanted at least partially in the septum (713) of the heart (701) of the patient, and to provide stimulation to the patient, wherein the distal end (31) comprises a fixing portion (31, 640, 801) configured to facilitate implanting in the septum (713); a sheath (50) having a three-dimensional opening for guiding the at least one electrode (30, 620, 800) for implanting of the electrode (30, 620, 800); wherein the generator (10, 610), the electrode (30, 620, 800) and the sheath (50) are adapted for use in combination with each other.

2. The system (100) of claim 1, wherein the generator comprises at least one predefined parameter configured to indicate a position of the electrode (30, 620, 800), preferably of the distal end (31) of the electrode (30, 620, 800) when implanted in the septum (713) of the heart (701).

3. The system (100) of claim 1 to 2, wherein the generator (10, 610) comprises stimulation and / or diagnostic functions that are configured to be dependent upon a location of the distal end (31) of the electrode (30, 620, 800).

4. The system (100) of claim 1 to 3, wherein the fixing portion comprises a helical structure having a length of 0.1 to 5 mm, preferably 0.5 to 4 mm, preferably 1 to 3 mm, most preferably 1.5 to 1.8 mm, the helical structure configured to allow the distal end (31) of the electrode (30, 620, 800) to be screwed in the septum (713), wherein the helical structure is preferably a piece separate from the electrode such that the helical structure can be at least partially removably attached to the electrode.

5. The system (100) of claim 1 to 4, wherein the fixing portion comprises a first pole (31, 640, 801) and the electrode (30, 620, 800) comprises a second pole (35, 650, 802) in proximity of the distal end (31), preferably between 1 to 10 mm, preferably 2 to 9 mm, preferably 3 to 8 mm, preferably 4 to 7 mm, preferably 5 to 6 mm spaced apart from the distal end (31), the first and the second pole (31, 35, 640, 650, 801, 802) configured to provide stimulation to the patient, wherein the electrode (30, 620, 800) is preferably a bipolar electrode, wherein the second pole (35) has preferably the shape of a ring, preferably having a length along the longitudinal direction of the electrode (30, 620, 800) of at least 0.5 mm, preferably at least 1 mm, preferably at least 1.5 mm, preferably at least 2 mm and / or of at most 5 mm, preferably at most 4 mm, preferably at most 3 mm, preferably at most 2 mm.

6. The system (100) of claim 1 to 5, wherein the sheath (50) has an inner surface facing the opening, wherein the inner surface is configured so as to facilitate guiding the electrode (30, 620, 800).

7. The system (100) of claim 1 to 6, wherein the stimulation is configured to provide left bundle branch area pacing, wherein the system (100) is preferably a conduction system pacing system.

8. The system of claim 1 to 7, wherein the generator (10, 610) is one or more of an implantable pulse generator, IPG, an implantable cardioverter defibrillator, ICD, a generator for cardiac resynchronization therapy with a defibrillator, CRT-D, a generator for cardiac resynchronization therapy with a pacemaker, CRT-P.

9. The system of claim 1 to 8, wherein the generator comprises a recess (11) for being engaged with the proximal end of the electrode (30, 620, 800), the recess (11) comprising a first (12) and a second (13) pole for transmitting the stimulation signal to the electrode (30, 620, 800) when the electrode (30, 620, 800) is engaged with the recess, wherein the generator (610) preferably comprises a second recess for being engaged with a further electrode, the second recess comprising a terminal, preferably an IS-1 terminal, wherein the further electrode is preferably an electrode configured tobe implanted to provide stimulation to a left bundle branch area of the heart of the patient or not to provide stimulation to a left bundle branch area of the heart of the patient.

10. The system of claim 1 to 9, wherein the generator (10, 610) comprises a programming interface comprising a switch configured to indicate whether or not the electrode (30, 620, 800) is implanted in the left bundle branch area of the heart (701) of the patient, wherein the switch is configured to be activated when the electrode (30, 620, 800) is implanted in the left bundle branch area of the heart (701) of the patient.

11. The system of claim 10, wherein, when the switch is activated, the information that the electrode (30, 620, 800) is implanted in the left bundle branch area of the heart (701) of the patient is configured to be indicated to a human, such as the patient, wherein preferably a brady parameter screen and / or a follow-up screen is / are configured to display this information, wherein this information is preferably configured to be made available on programmer printouts, wherein this information is preferably configured to be uploaded to remote monitoring system, HMSC.

12. The system of claim 10 or 11, wherein, when the switch is activated, a human such as the patient is allowed to enter left bundle branch, LBB, myocardial-only and / or Bundle branch block, BBB, correction capture threshold(s) separately or in combination for a substantially manual LV-threshold-test.

13. The system of claim 10 to 12, wherein providing stimulation to the patient is dependent on the information.

14. The system of claim 1 to 13, wherein the opening of the sheath (50) comprises a stylet and / or wherein the sheath (50) comprises a stylet, wherein the sheath (50) is preferably a catheter.

15. The system of claim 1 to 14, wherein the sheath (50) comprises a first deformation in a first plane and a second deformation in a second plane, the second plane being different from the first plane, wherein the sheath (50) is configured to be cut so as to facilitate removal of the sheath preferably after implanting the electrode, wherein preferably a tool can be used in order to cut the sheath.

Images